FDA Response to Kratom

The natural botanical substance known the world over as kratom is not without its controversies. For centuries, people have used the plant-based substance in traditional medicine, particularly in its native region of southeast Asia. After it began to be imported into the United States, a number of federal regulatory agencies have focused on it, claiming it represents a serious health risk to American citizens. The U.S. Food and Drug Administration (FDA) has taken the lead on pushing for a kratom ban.

What is Kratom?

Native to southeast Asian countries like Indonesia, Papua New Guinea, Thailand, and Malaysia, kratom is a natural substance produced from the leaves of Mitragyna speciosa, an evergreen shrub closely related to the coffee plant. In traditional medicine, the leaves of the plant were chewed to relieve pain or brewed into a tea to combat infections, digestive disorders, and boosting energy levels. Of the 40 or more active chemical compounds in the kratom plant, two psychoactive compounds known as mitragynine and 7-hydroxymitragynine have received the most attention.

Depending on the dosage, kratom can produce stimulant-like or pain-relieving effects. In the Western world, it has become popular in recent years as a natural alternative to potentially dangerous opioid painkillers. It can also be used to fight the symptoms of opioid withdrawal. It has also developed a recreational following, with users brewing a tea from the powdered leaves or by smoking the leaves.

Government Scrutiny

Despite kratom’s potential to provide pain relief and relief from drug withdrawal symptoms, among other health benefits, the substance is not well studied in the medical community beyond a few limited investigations.

The FDA, in concert with the U.S. Drug Enforcement Administration (DEA) proposed a complete ban on the importation, sale, and distribution of kratom in the United States in September 2016. The DEA even proposed to classify the natural plant substance as a Schedule 1 drug with a high abuse potential and no medical value; other drugs in the Schedule 1 classification include heroin, LSD, and methamphetamine. The FDA opened a public commenting period after announcing it would push for an importation ban and was surprised at the vocal public outcry supporting kratom and its potential for treating a number of medical conditions.

The FDA has issued warning letters and advisory alerts since it first attempted a ban, arguing that kratom isn’t safe and represents substantial risks as an uncontrolled and unapproved substance.

The agency has claimed that kratom-related deaths have risen along with calls to poison control centers and a salmonella scare arising from a tainted shipment of kratom. Industry advocacy groups like the Kratom Trade Association (KTA), an organization founded by entrepreneur and ethnobotanical expert Sebastian Guthery, have joined forces with kratom enthusiasts, scientists, medical professionals, and other organizations to push back against any potential bans.

The KTA believes that banning the importation of kratom will negatively affect thousands of patients who rely on the substance to treat chronic pain. A ban will also impact scientific studies that seek to unlock new medical applications for the natural plant substance.